Medical device bending devices and methods of use

ABSTRACT

Medical device bending devices and methods of use are disclosed herein. An embodiment includes a body, a handle in rotatable relationship with the body, and a head that is coupled with the handle in such a way that when the handle is rotated the head is drawn at least partially into the body and towards the handle. A terminal end of the body that is opposite of the handle and the head cooperate as a vise that bends opposing arms of a surgical staple from an inwardly angled configuration to a parallel configuration (or at angles therebetween) when a crown of the surgical staple is clamped in the vise.

FIELD OF THE PRESENT DISCLOSURE

Embodiments of the present disclosure are directed to surgicalinstruments, and more particularly, to but not by limitation, to medicaldevice bending devices/apparatuses that are configured to bend, forexample, surgical staples.

SUMMARY

According to some embodiments, the present disclosure is directed to adevice, comprising: a body; a handle in rotatable relationship with thebody; and a head that is coupled with the handle in such a way that whenthe handle is rotated, the head is drawn partially into the body andtowards the handle, wherein a terminal end of the body that is oppositeof the handle and the head cooperate as a vise, the vise clamping acrown of a surgical staple in such a way that ends of opposing arms ofthe surgical staple that extend from the crown move away from oneanother.

According to some embodiments, the present disclosure is directed to amethod, comprising: inserting a surgical staple in a device, the devicecomprising: a body; a handle in rotatable relationship with the body;and a head that is coupled with the handle in such a way that when thehandle is rotated, the head is drawn partially into the body and towardsthe handle, wherein a terminal end of the body that is opposite of thehandle and the head cooperate as a vise that bends opposing arms of asurgical staple from the inwardly angled configuration to a parallelconfiguration when a crown of the surgical staple is clamped in thevise; and rotating the handle to transition the surgical staple from theinwardly angled configuration to a parallel configuration.

According to some embodiments, the present disclosure is directed to akit, comprising: a surgical staple in an initial inwardly angledconfiguration (a shape memory material staple); and a device comprising:a body; a handle in rotatable relationship with the body; and a headthat is coupled with the handle in such a way that when the handle isrotated, the head is drawn partially into the body and towards thehandle, wherein a terminal end of the body that is opposite of thehandle and the head cooperate as a vise that bends opposing arms of asurgical staple from the inwardly angled configuration to a parallelconfiguration when a crown of the surgical staple is clamped in thevise.

The kit can also include a pilot hole jig and pilot hole drill forcreating pilot holes in a patient. The pilot hole jig has jig cylindersspaced apart from one another so as to create spacing between the pilotholes that correspond to a spacing of ends of the surgical staple whenin the parallel configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, together with the detailed description below, are incorporated inand form part of the specification, and serve to further illustrateembodiments of concepts that include the claimed disclosure, and explainvarious principles and advantages of those embodiments.

The methods and systems disclosed herein have been represented whereappropriate by conventional symbols in the drawings, showing only thosespecific details that are pertinent to understanding the embodiments ofthe present disclosure so as not to obscure the disclosure with detailsthat will be readily apparent to those of ordinary skill in the arthaving the benefit of the description herein.

FIG. 1 is a cross-sectional view of an example device constructed inaccordance with the present disclosure.

FIG. 2 includes plan views of the example device of FIG. 1 incombination with a surgical staple, where the surgical staple is in aninitial, inwardly bent configuration and a parallel configuration.

FIG. 3 is a perspective view of a head assembly of the device of FIG. 1.

FIG. 4 illustrates plan views of the body of the example device of FIG.1.

FIG. 5 is a perspective view of a kit comprising the device of FIG. 1 incombination with a pilot hole jig tool and a pilot hole drill bit.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

The present disclosure is directed, in some embodiments, to surgicalapparatuses, devices, kits, and methods of use that allow a user to bendsurgical staples from a first configuration to a second configuration.When in the second configuration, the surgical staple can be insertedinto a patient to secure structures together. Example structures includebone, skin, cartilage, and other similar structures that would be knownto one of ordinary skill in the art with the present disclosure beforethem.

In some embodiments, an example surgical device comprises a body that isconfigured to be gripped by a user. The surgical device also comprises ahandle in rotatable relationship with the body. In various embodiments,the surgical device comprises a head that is coupled with the handle insuch a way that when the handle is rotated, the head is drawn partiallyinto the body and towards the handle.

In one or more embodiments, the handle is rotatably coupled with thehead such that turning of the handle results in upward (e.g., towardsthe handle) movement of the head.

With respect to the bending of a surgical staple, the body and head ofthe surgical device form a vise that bends a crown of the surgicalstaple causing arms of the surgical staple to transition from aninwardly angled configuration to a parallel configuration. That is, thesurgical staple is transitioned when the handle is turned, which resultsin the head being drawn towards a terminal end of the body, therebypinching or compressing the crown of the staple.

Stated otherwise, the vise clamps a crown of a surgical staple in such away that ends of opposing arms of the surgical staple that extend fromthe crown move away from one another.

The devices of the present disclosure are adapted to bending medicaldevices, such as surgical staples that are manufactured from shapememory alloy material. When the staple is removed from an example deviceafter insertion of the surgical staple into the patient, the surgicalstaple returns to its initial configuration due to its shape memorymaterial properties.

These and other advantages of the present disclosure are described ingreater detail infra with respect to the collective drawings FIGS. 1-5.

FIG. 1 is a cross sectional view of an example device 100, such as asurgical staple bending apparatus. The device 100 generally comprises ahandle assembly 102, a body assembly 104, and a head assembly 106. Insome embodiments, the handle assembly 102 comprises a handle 108 and ashaft 110. In various embodiments, the shaft 110 has a threaded end 112that is configured for threaded engagement of the head assembly 106, aswill be discussed in greater detail infra.

According to some embodiments, the shaft 110 is inserted through thebody assembly 104 allowing the handle 108 to rotate about a first end orhandle end of the body assembly 104.

Turning to the body assembly 104; it comprises a body 114 and protrusion116 that forms a first portion of a vise 122. In some embodiments, thebody 114 comprises a handle end 118 and a terminal end 120 that isopposite to the handle end 118. In some embodiments, the body 114 hascurved surfaces that allow a user to easily grip and/or manipulate thebody 114 (and by extension the device 100).

In accordance with the present disclosure, the body 114 comprises alinear passage 124 that provides a pathway from the handle end 118 tothe terminal end 120. The linear passage 124 can comprise a cylindricalaperture that is sized to receive the shaft 110 of the handle assembly102. The shaft 110 can freely rotate within the linear passage 124 basedon rotation of the handle 108.

Also, the body 114 comprises a recess 126 that receives a portion of thehead assembly 106.

Referring briefly to FIG. 4, the body 114 comprises a channel 127 on thehandle end 118, as well as a channel 129 on the terminal end 120. Thedevice 100 can comprise either or both channels 127 and 129.Functionally, the channels provide mating interfaces that receive aportion of a surgical staple and allow the device 100 to be used as atool for imparting percussive force to the surgical staple. Thesefeatures are described in greater detail herein.

In one or more embodiments, the protrusion 116 comprises a hemisphericalprotrusion that at least partially overhangs a terminal end edge 128.The protrusion 116 also extends above an upper surface 117 of the body114.

The head assembly 106, in some embodiments, comprises a dowel 130 and ablock 132. The dowel 130 is configured for sliding insertion into therecess of the body 114. The dowel 130 comprises, in various embodiments,a threaded receiver 134. The threaded end 112 of the shaft 110 engageswith the threaded receiver 134.

Rotation of the handle 108 in a first direction causes the threaded end112 to drive into the threaded receiver 134, causing the dowel 130 to bedrawn inwardly into the recess 126 (towards the handle 108) and theblock 132 towards the terminal end 120 of the body 114. Rotation of thehandle 108 in a second direction that is opposite of the first directioncauses the threaded end 112 to be extracted from the threaded receiver134, allowing the dowel 130 and block 132 to translate away from thehandle 108.

Referring briefly to FIG. 3, according to some embodiments the block 132functions as a second portion of the vise 122. In some embodiments, theblock 132 comprises a flange 136 that extends from the dowel 130.Disposed on the flange 136 is a staple interface 138. The stapleinterface 138 comprises a groove 140 that is formed into a portion ofthe staple interface 138 at a terminal end of the flange 136.

In some embodiments, the groove 140 comprises rounded or arcuate ends142 and 144.

Referring to FIGS. 1-3 collectively, the protrusion 116 of the body 114and the groove 140 are coplanar with one another (as best illustrated inFIG. 1).

A surgical staple 146 can be cradled and held in place within the groove140, as illustrated in FIG. 1, where the surgical staple is illustratedin phantom dotted line so that the groove 140 is viewable. Morespecifically, and turning to FIG. 3, the surgical staple 146 comprises acrown 148 and two arms 150 and 152. Each of the arms 150 and 152 has anend. For example, arm 150 has an end 154 and the arm 152 has an end 156.

Turning now to FIG. 2, the surgical staple 146 is initially in aninwardly angled configuration C1 where the crown 148 is arcuate and theends 154 and 156 bend inwardly towards one another.

When surgical staple 146 is placed into the groove 140 in its inwardlyangled configuration C1, the arcuate shape of the crown 148 allows for aspace or gap 158 to exist between the crown 148 and a substantiallylinear portion 160 of the groove 140. This space 158 allows the crown148 to deflect towards the substantially linear portion 160 of thegroove 140 when the surgical staple 146 is clamped in the vise 122.Moreover, when the crown 148 is clamped in the vise 122, the crown 148will begin to straighten into a linear configuration from its originalarcuate configuration. Clamping of the crown 148 of the surgical staple146 will cause the ends 154 and 156 to splay and/or move away from oneanother. This can result in the arms 150 and 152 transitioning to asubstantially parallel configuration C2 (see FIG. 2). To be sure, notall embodiments and use cases require the surgical staple 146 to be inthe substantially parallel configuration C2. Therefore, transitioningthe surgical staple from the inwardly angled configuration C1 to anintermediate configuration that is less than the substantially parallelconfiguration C2 is also contemplated.

According to some embodiments, and turning to FIG. 3, the block 132comprises a pair of protrusions 162 and 164 that extend laterally fromthe block 132. These protrusions are disposed behind the groove 140.When the surgical staple 146 is coupled with the groove 140, a portionof the surgical staple 146 abuts or contacts the protrusions 162 and164. These protrusions 162 and 164 are optional in some embodiments. Theprotrusions can be used to support or stabilize the surgical staple 146during bending and/or insertion.

The device 100 can be comprised of any suitable material that is capableof being used in a surgical operation. Some embodiments can bemanufactured from materials that are amenable to sterilization and otherembodiments may be manufactured from materials that allow forsterilization and reuse.

In operation, a user can utilize the device 100 to bend the surgicalstaple 146. The user can ensure that a space is created between theterminal end 120 of the body 114 and the groove 140 of the block 132 ofthe head assembly 106 so that the surgical staple 146 can be insertedinto the groove 140 of the block 132. Once in position, the user canbegin to turn the handle 108 which rotates the shaft 110 causing thethreaded end 112 to drive into the threaded receiver 134 of the dowel130. This in turn, causes the dowel 130 to translate upwardly into therecess 126 of the body 114 towards the handle 108. Upward movement ofthe dowel 130 causes the block 132 to be drawn into proximity of theprotrusion 116 on the body 114. The surgical staple 146 begins to bendwhen the crown 148 is clamped between the protrusion 116 of the body 114and the groove 140 of the block 132. In more detail, as the block 132brings the crown 148 into contact with the protrusion 116, the gap 158between the crown 148 and the groove 140 begins to reduce in size. Asthe crown 148 is compressed between the block 132 and the protrusion116, the ends 154 and 156 begin to move away from one another.

When the handle 108 has been turned enough so that it contacts thehandle end 118 of the body 114, the crown 148 is approximatelycompressed flatly (or is in mating contact in some embodiments) againstthe substantially linear portion 160 of the groove 140. In thisposition, the arms 150 and 152 of the surgical staple 146 areapproximately parallel (or completely parallel) with one another. Statedotherwise, the compression of the crown 148 of the surgical staple 146between the protrusion 116 and block 132 causes the arms 150 and 152 tosplay outwardly from the inwardly angled configuration C1 to theparallel configuration C2.

In some embodiments, the shaft 110 is sized in length such that when thehandle 108 contacts the handle end 118 of the body 114, the crown 148 ofthe surgical staple 146 is compressed between the block 132 and theprotrusion 116 to place the arms 150 and 152 in parallel relationship toone another. Contact between the handle 108 and the handle end 118 ofthe body 114 then prevents further rotation of the handle 108, whichcould lead to over compression of the crown 148 of the surgical staple146 (e.g., over-bending of the surgical staple 146). Thus, the length ofthe shaft 110 can vary such that the surgical staple 146 cannot be bentfurther than required. This could be based on spacing between pilotholes that receive the arms 150 and 152 of the surgical staple 146. Thedetails of creating the pilot holes are described in greater detailinfra.

When inserted into the patient, the device 100 can be decoupled from thesurgical staple 146 by rotating the handle 108 in an opposing directionfrom the direction used to bend the surgical staple 146. When the handle108 is rotated in the reverse direction, the shaft 110 rotates so as tobegin to back out of the threaded receiver 134 of the dowel 130. Thiscauses the dowel 130 to move away from the handle 108, which in turncauses the block 132 and the protrusion 116 to separate. When the block132 and the protrusion 116 are sufficiently separated, the surgicalstaple 146 is removed from the block 132. In accordance with the presentdisclosure, the surgical staple 146 can be driven further into thepatient using the body 114 of the device 100.

For example, the handle 108 and head assembly 106 can be removed fromthe body 114. Either of the channels 127 or 129 can be mated with thecrown 148 of the surgical staple 146. That is, the crown 148 fits intowhichever channel is selected. The user then applies a percussive forceto an opposing end of the body 114 that is not engaged with the crown148 driving the surgical staple 146 further into the patient, such asinto a bone of the patient.

FIG. 5 illustrates an example kit that comprises a device 100 of thepresent disclosure in combination with a pilot hole device 202 and pilotdrill bit 204. In some embodiments, the pilot hole device 202 comprisesa handle 206 and pilot hole jig 208. The pilot hole jig 208 comprisesjig cylinders 210 and 212 that are spaced apart from one another. Thepilot drill bit 204 is used to create pilot holes in a patientstructure, such as a bone. That is, when the pilot hole jig 208 ispositioned on the patient structure, the pilot drill bit 204 is insertedinto each of the jig cylinders 210 and 212 respectively. The pilot drillbit 204 is used to ream out pilot holes in the patient structure.

As mentioned above, spacing between the jig cylinders 210 and 212 is setso as to correspond to spacing between arms 150 and 152 (or ends 154 and156) of the surgical staple 146.

After creation of the pilot holes, the surgical staple 146 is bent inthe device 100 according to the method described supra. The arms 150 and152 of the surgical staple 146 are then inserted into the pilot holes.

In some embodiments, the kit further comprises one or more spikes 214and 216 that are used to fill pilot holes after creation with the pilothole jig 208 and the pilot drill bit 204.

Example uses for the devices of the present disclosure include, but arenot limited to orthopedic procedures. For example, the devices of thepresent disclosure can be used to fuse or secure together separatedsegments of a bone, such as two sections of a broken metatarsal bone.The user can place the pilot hole jig 208 onto mating ends of the brokenmetatarsal bone and pilot holes are drilled. A surgical staple is theninserted into the pilot holes. It will be understood that the surgicalstaple is bent prior to insertion into the pilot holes. In someembodiments, the surgical staple is manufactured from a resilientlybiased or shape memory material such as Nitinol™ The material propertiesof the surgical staple cause the surgical staple to return to itsinitial configuration (e.g., inwardly bent configuration C1, see FIG.2), which draws the mating ends of the broken metatarsal bone toward oneanother and holds the mating ends together to promote fusion.

While this technology is susceptible of embodiment in many differentforms, there is shown in the drawings and has been described in detailseveral specific embodiments with the understanding that the presentdisclosure is to be considered as an exemplification of the principlesof the technology and is not intended to limit the technology to theembodiments illustrated.

Although the terms first, second, etc. may be used herein to describevarious elements, components, regions, layers and/or sections, theseelements, components, regions, layers and/or sections should notnecessarily be limited by such terms. These terms are only used todistinguish one element, component, region, layer or section fromanother element, component, region, layer or section. Thus, a firstelement, component, region, layer or section discussed below could betermed a second element, component, region, layer or section withoutdeparting from the teachings of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be necessarily limiting of thedisclosure. As used herein, the singular forms “a,” “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. The terms “comprises,” “includes” and/or“comprising,” “including” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

Example embodiments of the present disclosure are described herein withreference to illustrations of idealized embodiments (and intermediatestructures) of the present disclosure. As such, variations from theshapes of the illustrations as a result, for example, of manufacturingtechniques and/or tolerances, are to be expected. Thus, the exampleembodiments of the present disclosure should not be construed asnecessarily limited to the particular shapes of regions illustratedherein, but are to include deviations in shapes that result, forexample, from manufacturing.

Any and/or all elements, as disclosed herein, can be formed from a same,structurally continuous piece, such as being unitary, and/or beseparately manufactured and/or connected, such as being an assemblyand/or modules. Any and/or all elements, as disclosed herein, can bemanufactured via any manufacturing processes, whether additivemanufacturing, subtractive manufacturing and/or other any other types ofmanufacturing. For example, some manufacturing processes include threedimensional (3D) printing, laser cutting, computer numerical control(CNC) routing, milling, pressing, stamping, vacuum forming,hydroforming, injection molding, lithography and/or others.

Any and/or all elements, as disclosed herein, can include, whetherpartially and/or fully, a solid, including a metal, a mineral, aceramic, an amorphous solid, such as glass, a glass ceramic, an organicsolid, such as wood and/or a polymer, such as rubber, a compositematerial, a semiconductor, a nano-material, a biomaterial and/or anycombinations thereof. Any and/or all elements, as disclosed herein, caninclude, whether partially and/or fully, a coating, including aninformational coating, such as ink, an adhesive coating, a melt-adhesivecoating, such as vacuum seal and/or heat seal, a release coating, suchas tape liner, a low surface energy coating, an optical coating, such asfor tint, color, hue, saturation, tone, shade, transparency,translucency, non-transparency, luminescence, anti-reflection and/orholographic, a photo-sensitive coating, an electronic and/or thermalproperty coating, such as for passivity, insulation, resistance orconduction, a magnetic coating, a water-resistant and/or waterproofcoating, a scent coating and/or any combinations thereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. Theterms, such as those defined in commonly used dictionaries, should beinterpreted as having a meaning that is consistent with their meaning inthe context of the relevant art and should not be interpreted in anidealized and/or overly formal sense unless expressly so defined herein.

Furthermore, relative terms such as “below,” “lower,” “above,” and“upper” may be used herein to describe one element's relationship toanother element as illustrated in the accompanying drawings. Suchrelative terms are intended to encompass different orientations ofillustrated technologies in addition to the orientation depicted in theaccompanying drawings. For example, if a device in the accompanyingdrawings is turned over, then the elements described as being on the“lower” side of other elements would then be oriented on “upper” sidesof the other elements. Similarly, if the device in one of the figures isturned over, elements described as “below” or “beneath” other elementswould then be oriented “above” the other elements. Therefore, theexample terms “below” and “lower” can, therefore, encompass both anorientation of above and below.

The description of the present disclosure has been presented forpurposes of illustration and description, but is not intended to beexhaustive or limited to the present disclosure in the form disclosed.Many modifications and variations will be apparent to those of ordinaryskill in the art without departing from the scope and spirit of thepresent disclosure. Exemplary embodiments were chosen and described inorder to best explain the principles of the present disclosure and itspractical application, and to enable others of ordinary skill in the artto understand the present disclosure for various embodiments withvarious modifications as are suited to the particular use contemplated.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. The descriptions are not intended to limit the scope of thetechnology to the particular forms set forth herein. Thus, the breadthand scope of a preferred embodiment should not be limited by any of theabove-described exemplary embodiments. It should be understood that theabove description is illustrative and not restrictive. To the contrary,the present descriptions are intended to cover such alternatives,modifications, and equivalents as may be included within the spirit andscope of the technology as defined by the appended claims and otherwiseappreciated by one of ordinary skill in the art. The scope of thetechnology should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.

What is claimed is:
 1. A device, comprising: a body comprising ahemispherical protrusion that comprises a first portion of a vise; ahandle in rotatable relationship with the body; and a head comprising adowel and a block, the block comprising a second portion of the vise,wherein the head is coupled with the handle in such a way that when thehandle is rotated the head is drawn at least partially into the body andtowards the handle, wherein a terminal end of the body that is oppositeof the handle and the head cooperate as a vise that bends opposing armsof a surgical staple from an inwardly angled configuration to a parallelconfiguration when a crown of the surgical staple is clamped in thevise.
 2. The device according to claim 1, further comprising a threadedshaft that couples the handle and the head.
 3. The device according toclaim 2, wherein the body comprises a linear passage that receives thethreaded shaft.
 4. The device according to claim 3, wherein an end ofthe threaded shaft is threaded onto the head.
 5. The device according toclaim 1, wherein the body comprises a recess that receives a dowel ofthe head.
 6. The device according to claim 1, wherein the hemisphericalprotrusion overhangs a terminal end edge.
 7. The device according toclaim 1, wherein the head comprises lateral protrusions that stabilizethe surgical staple.
 8. The device according to claim 7, wherein athreaded shaft comprises a length such that when the handle is rotatedto draw the head upwardly towards the handle, the handle contacts thebody to prevent over bending of the surgical staple beyond the parallelconfiguration.
 9. The device according to claim 1, further comprising afirst channel extending along a handle end of the body.
 10. The deviceaccording to claim 9, further comprising a second channel extendingalong the terminal end of the body.
 11. A kit, comprising: a surgicalstaple in an initial inwardly angled configuration; and a devicecomprising: a body comprising a hemispherical protrusion that comprisesa first portion of a vise; a handle in rotatable relationship with thebody; and a head comprising a dowel and a block, the block comprising asecond portion of the vise, the head being coupled with the handle insuch a way that when the handle is rotated the head is drawn partiallyinto the body and towards the handle, wherein a terminal end of the bodythat is opposite of the handle and the head cooperate as a vise thatbends opposing arms of a surgical staple from the inwardly angledconfiguration to a parallel configuration when a crown of the surgicalstaple is clamped in the vise.
 12. The kit according to claim 11,further comprising a pilot hole jig and pilot hole drill for creatingpilot holes in a patient, the pilot hole jig having jig cylinders spacedapart from one another so as to create spacing between the pilot holesthat correspond to a spacing of ends of the surgical staple when in theparallel configuration.
 13. The kit according to claim 12, furthercomprising one or more spikes that fill one or more of the pilot holesprior to insertion of the surgical staple in the pilot holes.
 14. Adevice, comprising: a body; a handle in rotatable relationship with thebody; and a head that is coupled with the handle in such a way that whenthe handle is rotated the head is drawn at least partially into the bodyand towards the handle, wherein a terminal end of the body that isopposite of the handle and the head cooperate as a vise that bendsopposing arms of a surgical staple from an inwardly angled configurationto a parallel configuration when a crown of the surgical staple isclamped in the vise, wherein a block of the head comprises a groovehaving arcuate ends, the groove receiving a portion of the surgicalstaple.